Search result: YY 0096-2019 (YY 0096-2009 Older version)
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| YY 0096-2019 | English | 279 |
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Co-60 teletherapy unit
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YY 0096-2019
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| YY 0096-2009 | English | 479 |
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Co-60 teletherapy unit
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YY 0096-2009
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| YY 0096-1992 | English | 599 |
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Cobalt-60 telecobalt machine
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YY 0096-1992
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| Standard ID | YY 0096-2019 (YY0096-2019) | | Description (Translated English) | Co-60 teletherapy unit | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C43 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 14,138 | | Date of Issue | 2019 | | Date of Implementation | 2020-12-01 | | Summary | This standard specifies the requirements and test methods for cobalt-60 teletherapy machines. This standard applies to cobalt-60 teletherapy machine (hereinafter referred to as the treatment machine), which is mainly used for radiotherapy in medical institutions. |
YY 0096-2019
Co-60 teletherapy unit
ICS 11.040.60
C43
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0096-2009
Cobalt-60 teletherapy machine
Published on.2019-05-31
2020-12-01 implementation
State Drug Administration issued
Content
Foreword III
1 range 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 1
4.1 Environmental conditions 1
4.2 Performance 2
4.3 Electrical Safety 3
5 Test method 3
5.1 Test conditions 3
5.2 Performance 3
5.3 Electrical Safety 7
Appendix A (Normative Appendix) Method of Measuring Absorbed Dose Rate 8
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0096-2009 "Cobalt-60 Teletherapy Machine".
Compared with YY 0096-2009, the main technical changes except the editorial modification are as follows.
--- Removed the introduction (see the introduction of the.2009 edition);
--- Normative references have added GB/T 17857 and YY 0505 (see 2);
--- Revised some terms and definitions (see 3, 3 of the.2009 edition);
--- Removed "type and basic parameters" (see 4 of the.2009 edition);
--- Increased performance requirements for the treatment bed (see 4.2.10);
--- Increased the requirement for absorbed dose rate (see 4.2.11);
--- Revised the test method for the error of the isocenter position (see 5.2.1, 6.5 of the.2009 edition);
--- Revised the test method for the trimmed penumbra width (see 5.2.2, 6.6 of the.2009 edition);
--- Revised the test method for the deviation between the field and the radiation field boundary (see 5.2.5, 6.9 of the.2009 edition);
--- Revised the test method for the display of the radiation field (see 5.2.8, 6.12 of the.2009 edition);
--- Revised electrical safety requirements and test methods (see 4.3, 5.3,.2009 editions 5.14, 6.15);
--- Removed "noise" (see 5.11 of the.2009 edition);
--- Removed the "look" (see 5.12 of the.2009 edition);
--- Removed the "ruler scale" (see 5.13 of the.2009 edition);
--- Removed the "radiation head movement" [see.2009 edition of 5.7a)];
--- Removed the "inspection rules" (see 7 of the.2009 edition);
--- Removed "flag, packaging, transportation, storage" (see 8 of.2009 edition);
--- Removed the appendix "Test methods for isocenter locations" (see Appendix A of the.2009 edition);
--- Added "Measurement method for absorbed dose rate" (see Appendix A).
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is divided into the Technical Committee of Radiotherapy, Nuclear Medicine and Radiation Dosimetry Equipment of the National Medical Electrical Equipment Standardization Technical Committee.
(SAC/TC10/SC3) is under the jurisdiction.
This standard was drafted. Beijing Medical Device Inspection Institute, Shandong Xinhua Medical Instrument Co., Ltd., China Nuclear Power Research and Design
Hospital equipment manufacturing plant.
The main drafters of this standard. Jiao Chunying, Cheng Xige, Ma Binren, Huang Jifa, Xu Xiang, Yu Bin.
The previous versions of the standards replaced by this standard are.
---YY 0096-1992, YY 0096-2009.
Cobalt-60 teletherapy machine
1 Scope
This standard specifies the requirements and test methods for the Cobalt-60 remote treatment machine.
This standard applies to the cobalt-60 remote treatment machine (hereinafter referred to as the treatment machine), which is mainly used for medical treatment for radiation therapy.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety
GB 9706.17 Medical electrical equipment - Part 2. Particular requirements for safety of gamma beam therapy equipment
GB/T 17857 Medical radiology terms (radiation therapy, nuclear medicine and radiation dosimetry equipment)
YY 0505 Medical electrical equipment - Part 1-2. Safety general requirements. Parallel standard. Electromagnetic compatibility requirements and testing
3 Terms and definitions
The following terms and definitions as defined in GB 9706.1, GB 9706.17 and GB/T 17857 apply to this document.
3.1
Radiation head radiationhead
A mechanism that stores functions such as storing a radiation source and emitting a radiation beam.
3.2
Penumbra penumbra
Since the source is a non-point source, there is a certain volume, and the scattering of the rays in the radiation field and the thickness of the useful rays passing through the collimator are inconsistent,
Make a certain gradient from large to small in the vicinity of the determined radiation field edge, 80% absorbed dose at the radiation beam axis in the radiation range
Point and the area covered by the 20% absorbed dose point.
3.3
(gamma beam) teletherapy (gammabeam) teletherapy
The distance (SSD) between the radiation source and the skin is not less than the gamma ray beam emitted by the radionuclide placed in the radiation source assembly.
External beam medical treatment performed at 50 cm.
4 requirements
4.1 Environmental conditions
Unless otherwise stated in the documentation, the following conditions should be met.
a) Ambient temperature range. 10 ° C ~ 40 ° C;
b) Relative humidity range. 30%~75%;
c) Atmospheric pressure range. 70kPa~106kPa.
YY 0096-2019
Co-60 teletherapy unit
ICS 11.040.60
C43
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0096-2009
Cobalt-60 teletherapy machine
Published on.2019-05-31
2020-12-01 implementation
State Drug Administration issued
Content
Foreword III
1 range 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 1
4.1 Environmental conditions 1
4.2 Performance 2
4.3 Electrical Safety 3
5 Test method 3
5.1 Test conditions 3
5.2 Performance 3
5.3 Electrical Safety 7
Appendix A (Normative Appendix) Method of Measuring Absorbed Dose Rate 8
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0096-2009 "Cobalt-60 Teletherapy Machine".
Compared with YY 0096-2009, the main technical changes except the editorial modification are as follows.
--- Removed the introduction (see the introduction of the.2009 edition);
--- Normative references have added GB/T 17857 and YY 0505 (see 2);
--- Revised some terms and definitions (see 3, 3 of the.2009 edition);
--- Removed "type and basic parameters" (see 4 of the.2009 edition);
--- Increased performance requirements for the treatment bed (see 4.2.10);
--- Increased the requirement for absorbed dose rate (see 4.2.11);
--- Revised the test method for the error of the isocenter position (see 5.2.1, 6.5 of the.2009 edition);
--- Revised the test method for the trimmed penumbra width (see 5.2.2, 6.6 of the.2009 edition);
--- Revised the test method for the deviation between the field and the radiation field boundary (see 5.2.5, 6.9 of the.2009 edition);
--- Revised the test method for the display of the radiation field (see 5.2.8, 6.12 of the.2009 edition);
--- Revised electrical safety requirements and test methods (see 4.3, 5.3,.2009 editions 5.14, 6.15);
--- Removed "noise" (see 5.11 of the.2009 edition);
--- Removed the "look" (see 5.12 of the.2009 edition);
--- Removed the "ruler scale" (see 5.13 of the.2009 edition);
--- Removed the "radiation head movement" [see.2009 edition of 5.7a)];
--- Removed the "inspection rules" (see 7 of the.2009 edition);
--- Removed "flag, packaging, transportation, storage" (see 8 of.2009 edition);
--- Removed the appendix "Test methods for isocenter locations" (see Appendix A of the.2009 edition);
--- Added "Measurement method for absorbed dose rate" (see Appendix A).
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is divided into the Technical Committee of Radiotherapy, Nuclear Medicine and Radiation Dosimetry Equipment of the National Medical Electrical Equipment Standardization Technical Committee.
(SAC/TC10/SC3) is under the jurisdiction.
This standard was drafted. Beijing Medical Device Inspection Institute, Shandong Xinhua Medical Instrument Co., Ltd., China Nuclear Power Research and Design
Hospital equipment manufacturing plant.
The main drafters of this standard. Jiao Chunying, Cheng Xige, Ma Binren, Huang Jifa, Xu Xiang, Yu Bin.
The previous versions of the standards replaced by this standard are.
---YY 0096-1992, YY 0096-2009.
Cobalt-60 teletherapy machine
1 Scope
This standard specifies the requirements and test methods for the Cobalt-60 remote treatment machine.
This standard applies to the cobalt-60 remote treatment machine (hereinafter referred to as the treatment machine), which is mainly used for medical treatment for radiation therapy.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety
GB 9706.17 Medical electrical equipment - Part 2. Particular requirements for safety of gamma beam therapy equipment
GB/T 17857 Medical radiology terms (radiation therapy, nuclear medicine and radiation dosimetry equipment)
YY 0505 Medical electrical equipment - Part 1-2. Safety general requirements. Parallel standard. Electromagnetic compatibility requirements and testing
3 Terms and definitions
The following terms and definitions as defined in GB 9706.1, GB 9706.17 and GB/T 17857 apply to this document.
3.1
Radiation head radiationhead
A mechanism that stores functions such as storing a radiation source and emitting a radiation beam.
3.2
Penumbra penumbra
Since the source is a non-point source, there is a certain volume, and the scattering of the rays in the radiation field and the thickness of the useful rays passing through the collimator are inconsistent,
Make a certain gradient from large to small in the vicinity of the determined radiation field edge, 80% absorbed dose at the radiation beam axis in the radiation range
Point and the area covered by the 20% absorbed dose point.
3.3
(gamma beam) teletherapy (gammabeam) teletherapy
The distance (SSD) between the radiation source and the skin is not less than the gamma ray beam emitted by the radionuclide placed in the radiation source assembly.
External beam medical treatment performed at 50 cm.
4 requirements
4.1 Environmental conditions
Unless otherwise stated in the documentation, the following conditions should be met.
a) Ambient temperature range. 10 ° C ~ 40 ° C;
b) Relative humidity range. 30%~75%;
c) Atmospheric pressure range. 70kPa~106kPa.
......
YY 0096-2009
Co-60 teletherapy unit
ICS 11.040.60
C43
People's Republic of China pharmaceutical industry standards
Replacing YY 0096-1992
Cobalt-60 teletherapy machine
Posted 2009-06-16
2010-12-01 implementation
State Food and Drug Administration issued
Foreword
This standard replaces YY 0096-1992 "cobalt-60 teletherapy machine."
Appendix A of this standard is a normative appendix.
This standard was proposed by the State Food and Drug Administration.
This standard by the national radiotherapy, nuclear science equipment for Standardization Technical Committee centralized medical and radiation dose.
This standard by Shandong Xinhua Medical Instrument Co., Ltd., Beijing Medical Device Testing is responsible for drafting.
The main drafters of this standard. Yang Haifeng, a Greek leather, Miao Bin, Huang Ji hair.
This standard was first published in 1992, the first revision in 2009.
introduction
If the cobalt-60 teletherapy machine is not in accordance with the requirements of radiation or the device is not designed to meet the medical electrical equipment safety standard
Accurate, can make patients suffer. If the shield shielding device itself or the treatment room does not meet the standard, devices in the vicinity might
It is compromised.
Requirements of this standard as a manufacturer in the design, manufacture based on cobalt-60 teletherapy unit from.
Cobalt-60 teletherapy machine
1 Scope
This standard specifies the cobalt-60 teletherapy machine (hereinafter referred to as the treatment machine) the type and basic performance parameters, technical requirements, test side
Content method, inspection rules.
This standard applies to cobalt-60 teletherapy machine, the machine primarily for medical radiotherapy units for use.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB 9706.1 Medical Electrical Equipment Part 1. General Requirements for Safety (GB 9706.1-2007, IEC 60601-1. 1988,
IDT)
GB 9706.17 Medical electrical equipment - Part 2. γ beam therapy equipment requirements for the safety (GB 9706.17-1999,
idt IEC 60601-2-11.1997)
GB/T 18987 Radiotherapy equipment Coordinates, movements and scales
YY 0076 coating metal parts classification, technical conditions
3 Terms and Definitions
The following terms and definitions apply to this standard.
3.1
Storage of radioactive sources and radiation beams having other functions of the institution is issued.
3.2
Because radioactive non-point source, a certain volume, and the radiation field within ray scattering and useful rays by the collimator thickness is inconsistent,
So that the radiation field is determined near the edge of a descending dose gradient region, this area is called the penumbra.
4 Types and basic parameters
4.1 Treatment Machine Type. Rotary or lift.
4.2 treatment machine should include the following major components.
4.2.1 Rotary
It includes the following main components.
a) frame;
b) pivot arm;
c) irradiation head;
d) collimator;
e) a counterweight;
f) base;
g) treatment couch.
......
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